Internal balloon sheath

ABSTRACT

Devices and methods for providing an internal balloon sheath are disclosed. One device includes a sheath for insertion through an arteriotomy of a patient. The sheath comprises a tubular sheath body having a longitudinal axis, an open proximal end, an open distal end, an outer surface and an inner surface, the inner surface defining a lumen between the proximal and distal ends for passage of a catheter device. The sheath also comprises an inflatable balloon disposed within the lumen. The inflatable balloon is configured to occupy a longitudinal space in the lumen between the inner surface of the sheath body and the catheter device when the catheter device is disposed within the sheath and the balloon is inflated, and fluidically seal the lumen.

BACKGROUND

Intravascular medical devices may comprise, but are not limited to, anImpella® pump, an Extracorporeal Membrane Oxygenation (ECMO) pump, and aballoon pump. The Impella® pump may further comprise an Impella 2.5®pump, an Impella 5.0® pump, an Impella CP® pump and an Impella LD® pump,all of which are by Abiomed, Inc. of Danvers, Mass. Most intravascularmedical devices are catheter devices that have an operational unit, suchas a pump head, at the distal end of the catheter. Such operationalunits have a larger diameter compared to the catheter body supportingthem. These devices often require introducer sheaths to position them inthe desired location within the arteriotomy of the patient before theycan be operated. The introducer sheaths are usually dimensioned suchthat the pump head can easily traverse through the sheath without beingdamaged, i.e. the inner diameter of the introducer sheath is oftenlarger than the outer diameter of the pump head.

The difference between the inner diameter of the introducer sheath andthe outer diameter of the catheter body gives rise to the development ofa space between the introducer sheath and the catheter body after thepump head has been deployed from the distal end of the introducersheath. This leads to blood ingress and stagnation within the sheath, inthe space between the introducer sheath and the catheter body, whichwill eventually lead to clotting. When a clot forms between the sheathand intravascular medical device several issues may arise. If the clotforms at the distal tip of the sheath it may be accidentally brokenfree, embolizing downstream (such as, for example, into distal limb, upto right heart and lungs, etc.). The rate of occurrence of theseclinical scenarios is increased when the procedure requires the deviceand sheath to be left in place for durations longer than several hoursor at times where anticoagulation is limited.

Currently, when there is a space between the inner surface of theintroducer sheath and the outer surface of the catheter of theintravascular medical device, physicians will setup the sheath so that acontinuous flow of saline or heparinized saline flushes through thespace, often at a flow rate of 3cc/hr, for example. Typically thisprevents clot formation, although it requires additional setup, fluiddelivery to the patient, and risk of mismanagement leading to clinicalcomplications. This issue has not been addressed by sheath manufacturersas it is assumed that introducer sheaths and the like are not for longterm use. In some cases sheath manufacturers have not found a suitabletechnical solution, are unaware of the clinical issue, or believe theproblem should be solved by the intravascular device manufacturer.

Additionally, intravascular medical devices that sit in the leftventricle across the aortic valve may be very sensitive to positioningissues. For example, if the device travels too far into or out of theheart the hemodynamic support may be compromised leading to patientharm. Long term use of an introducer sheath with an intravascularmedical device threaded therethrough runs the risk of the device beingdislodged from its initial position as the patient moves. Currently,physicians attempt to fix the position of the intravascular medicaldevices relative to the patient by coupling the proximal end of thesheath of a hub, or fixing the distal end of the device directly to thepatient outside the body (for example, to the patient's skin usingtape). This often requires additional geometry or design that may bebulky. In some scenarios this may be forgotten by the user and theattachment may subsequently come detached.

SUMMARY

Disclosed herein are approaches for addressing various problems andshortcomings of the state of the art, as identified above. Moreparticularly, disclosed herein are devices for delivery of a catheterdevice to an arteriotomy of a patient using a sheath with an internalballoon. In one embodiment, the sheath comprises a tubular sheath bodyhaving a longitudinal axis, an open proximal end, an open distal end, anouter surface and an inner surface, the inner surface defining a lumenbetween the proximal and distal ends for passage of the catheter device.The sheath also comprises an inflatable balloon configured to occupy alongitudinal space in the lumen between the inner surface of the sheathbody and the catheter device when the catheter device is disposed withinthe sheath and the balloon is inflated, and fluidically seal the lumen.

In some implementations, the balloon may form an interference fitbetween the catheter device and the inner surface of the sheath bodywhen inflated. In certain implementations, the balloon may be positionedat least at the distal end of the sheath body. In other implementations,the balloon may be positioned along the entire length of the sheathbody. In further implementations, the balloon may be attached to theinner surface of the sheath body. In some implementations, the balloonmay be attached at least at the distal end of the inner surface of thesheath body. In certain implementations, the balloon may be attachedalong the entire length of the inner surface of the sheath body. Inother implementations, the balloon may be attached along at least aportion of the circumference of the sheath body. In furtherimplementations, the balloon may be attached along at least any of thefollowing portions of the sheath body: about 25%, about 50%, about 75%,about 100% of the inner circumference of the sheath body.

In some implementations, the inner surface of the sheath body may bepretreated to improve attachment of the balloon to the inner surface ofthe sheath body. In certain implementations, the balloon may be attachedto the inner surface of the sheath body via heat or solvent bond. Inother implementations, the inner surface of the sheath body may bepretreated via any one of: plasma activation and coronary treatment. Infurther implementations, the balloon may be inflated via an inflationopening located on the inner surface of the distal end of the sheathbody. In some implementations, the sheath body may comprise an inflationlumen that extends from the proximal end of the sheath body to theinflation opening. In certain implementations, the inflation lumen maybe in fluid communication with the inflation opening. The inflationlumen may extend along the length of the sheath body linearly orcurvilinearly.

In some implementations, the sheath may further comprise a balloonsleeve on which the inflatable balloon is attached, the sleeve alignedin-line with the catheter device and configured to traverse the lumen ofthe sheath body. The proximal end of the balloon sleeve may comprise ahemostasis valve that seals with the catheter device. In certainimplementations, the balloon sleeve may comprise an inflation lumen influid communication with the balloon for inflation. In otherimplementations, the proximal end of the balloon sleeve may comprise aninflation port in fluid communication with the inflation lumen forinflation. In further implementations, the proximal end of the sheathbody may be coupled to an inflation port that is in fluid communicationwith the balloon for inflation. In some implementations, the inflationlumen may be in communication with a fixed volume syringe for inflationof the balloon at the proximal end of the sheath body. In certainimplementations, the balloon may be inflated via the inflation port withany one of: water, saline and air.

In some implementations, the balloon may be positioned in-line with thecatheter device. In other implementations, the balloon may be radiallysymmetric with respect to the longitudinal axis of the sheath body. Infurther implementations, the balloon may be ring-shaped through whichthe catheter device traverses. In certain implementations, the balloonmay apply a radial force on the catheter device when inflated, therebylocking the catheter device in position. In some implementations, theballoon may be asymmetric with respect to the longitudinal axis of thesheath body. The balloon may exert a force on the catheter device so asto push the catheter device towards a portion of the inner surface ofthe sheath body when inflated, thereby locking the catheter device inposition.

In certain implementations, the sheath body may comprise a lamination ofa plurality of polymer layers arranged coaxially with each other aboutthe longitudinal axis. In other implementations, the sheath body maycomprise a combination of a plurality of tubular polymer layer portionsarranged sequentially from the proximal to the distal end of the sheathbody. Each polymer layer may comprise a different polymer material type.In some implementations, the polymer material type may comprise any oneof: PEBAX® 7233SA, PEBAX® 7033SA, PEBAX® 6333SA, PEBAX® 5533SA, PEBAX®3533SA, and PEBAX® 2533SA.

In further implementations, the sheath body may comprise reinforcedstructures to prevent kinking. In other implementations, the reinforcedstructures may comprise any one of: braids, coils and laser cutfeatures. In some implementations, the balloon may be fabricated fromany one of: urethane, polyurethane, polyethylene, polypropylene,polyethylene terephthalate (PET), polyvinyl chloride (PVC),polyethylene, cross-linked polyethylene, a polyether block amide (PEBA),and nylon. In certain implementations, the sheath body may be fabricatedfrom any one of: a polyether block amide (such as PEBAX® or PebaSlix®),a polyethylene material, a polytetrafluoroethylene (PTFE) material, ahigh-density polyethylene (HDPE) material, a medium-density polyethylene(MDPE) material, and a low-density polyethylene (LDPE) material. Inother implementations, the distal end of the sheath body may befabricated from a softer elastic material than that used for the rest ofthe sheath body.

In further implementations, the distal end of the sheath body maycomprise a smaller diameter so as to seal onto the catheter device. Insome implementations, the balloon sleeve may be fabricated from any oneof: urethane, polyurethane, polyethylene, polypropylene, polyethyleneterephthalate (PET), polyvinyl chloride (PVC), polyethylene,cross-linked polyethylene, a polyether block amide (PEBA), and nylon.

In certain implementations, the balloon may be compliant and held flushagainst the inner surface of the sheath body when deflated. In otherimplementations, the balloon may be non-compliant and not held flushagainst the inner surface of the sheath body when deflated. In furtherimplementations, the balloon may be coated with either a hydrophiliccoating or a hydrophobic coating. The coating may be of a thickness thatensures appropriate balloon inflation characteristics. In someimplementations, the sheath body may deform when the balloon isinflated, thereby fixing the position of the sheath in the arteriotomyof the patient.

In some implementations, the proximal end of the sheath may be coupledto a hub for manipulating the sheath as it is positioned within thearteriotomy of the patient. In certain implementations, the hub maycomprise an inflation sideport that is in fluid communication with thefluid lumen, thereby enabling the attachment of a source of ballooninflation fluid. In other implementations, the hub may comprise anirrigation port that is in fluid communication with the space betweenthe catheter device and the inner surface of the sheath body, therebyenabling the space to be flushed with fluid prior to inflation of theballoon.

In another embodiment, a sheath kit is provided. The sheath kitcomprises a sheath and an inflation device coupled to the sheath. Thesheath comprises a tubular sheath body having a longitudinal axis, anopen proximal end, an open distal end, an outer surface and an innersurface, the inner surface defining a lumen between the proximal anddistal ends for passage of the catheter device. The sheath alsocomprises an inflatable balloon configured to occupy a longitudinalspace in the lumen between the inner surface of the sheath body and thecatheter device when the catheter device is disposed within the sheathand the balloon is inflated, and fluidically seal the lumen. Theinflation device comprises a fixed volume syringe filled with fluid forthe inflatable balloon with the fluid.

In yet another embodiment, a method of fabricating a sheath with aninternal balloon is provided. The method comprises providing a tubularsheath body, the sheath body having a longitudinal axis, an openproximal end, an open distal end, an outer surface and an inner surface,the inner surface defining a lumen between the proximal and distal endsfor passage of a catheter device. The method then comprises providing aninflatable balloon positioned in the lumen, the balloon configured tooccupy a space in the lumen between the inner surface of the sheath bodyand the catheter device when the balloon is inflated thereby fluidicallysealing the lumen.

In some implementations, the method may further comprise attaching theinflatable balloon to at least a portion of the inner surface of thesheath body. In certain implementations, the method may comprisepretreating the inner surface of the sheath body to improve adhesionbetween the balloon and the inner surface of the sheath body. In otherimplementations, the pretreatment may comprise any one of: plasmaactivation and coronary treatment. In further implementations, themethod may comprise providing a balloon sleeve for insertion into thelumen of the sheath body, the sleeve aligned in-line with the catheterdevice, and attaching the inflatable balloon to at least a portion ofthe sleeve. In some implementations, attachment of the balloon iscarried out via heat or solvent bond.

In further implementations, the method may additionally comprise atleast one of: (i) coating the surface of the balloon with either ahydrophilic coating or a hydrophobic coating, (ii) coating the surfaceof the balloon up to a predetermined coating thickness to achieveparticular inflation characteristics of the balloon, and (iii) coatingthe catheter based medical device. In some implementations, the methodmay further comprise coupling a proximal end of the sheath body to ahub.

In a further embodiment, a method of using a sheath with an internalballoon for treating a patient with a catheter device is provided. Themethod comprises positioning a sheath in an arteriotomy of the patient.The method then comprises inserting the catheter device into the lumento position a distal end of the catheter device in the arteriotomy ofthe patient. Next the method comprises flushing the space with anirrigation fluid, and inflating the balloon with an inflation fluid soas to fluidically seal the lumen.

In some implementations, the method may comprise inserting a balloonsleeve on which the inflatable balloon is attached into the lumen, thesleeve aligned in-line with the catheter device.

In another embodiment, there is provided a method of using a sheath withan internal balloon for treating a patient with a catheter device. Themethod comprises the steps of inserting a sheath having a lumen runningtherethrough into the arteriotomy of the patient. The method alsocomprises inserting the catheter based device into the lumen. The methodthen includes the step of inflating a balloon within the lumen betweenthe sheath and the catheter based device so as to fluidically seal thelumen.

In some implementations, the method may comprise flushing the lumenprior to inflating the balloon. In certain implementations, insertingthe sheath may comprise inserting a dilator into the lumen of the sheathfor positioning the sheath into the arteriotomy of the patient. In someimplementations, the balloon may be attached to the sheath. In otherimplementations, the method may further comprise inserting a balloonsleeve, onto which the balloon is attached, into the lumen of the sheathbetween the sheath and the catheter based device, before inflating theballoon. In further implementations, the balloon sleeve may be tightlycoaxially arranged around the catheter based device.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantages will be apparent uponconsideration of the following detailed description, taken inconjunction with the accompanying drawings, in which like referencecharacters refer to like parts throughout, and in which:

FIG. 1 shows an illustrative sheath delivery system as known in theprior art used for delivering a catheter based device into anarteriotomy of a patient;

FIG. 2 shows an illustrative cross section of the sheath delivery systemof FIG. 1;

FIG. 3 shows the ingress of fluid and clots after the sheath deliverysystem of FIG. 1 has been inserted into the patient;

FIG. 4 shows an illustrative internal balloon sheath according to anembodiment of the present disclosure;

FIG. 5A shows an illustrative internal balloon sheath according to anembodiment of the present disclosure, in which the balloon is positionedat the distal end of the sheath;

FIG. 5B shows an illustrative internal balloon sheath according to anembodiment of the present disclosure, in which the balloon is positionedalong the entire length of the sheath;

FIG. 6 shows an illustrative inflation lumen and inflation port formedin the sheath body for inflating an internal balloon, according to anembodiment of the present disclosure;

FIG. 7 shows a radial cross section of the internal balloon sheath ofFIG. 6;

FIG. 8 shows the internal balloon sheath of FIG. 6 prior to inflation;

FIG. 9A shows an expanded view of an illustrative internal balloonsheath with an inline balloon sleeve according to an embodiment of thepresent disclosure;

FIG. 9B shows the internal balloon sheath of FIG. 9A with the inlineballoon sleeve inserted into internal balloon sheath;

FIG. 10A shows a radial cross section of the internal balloon sheath ofFIGS. 9A-9B prior to inflation;

FIG. 10B shows a radial cross section of the internal balloon sheath ofFIGS. 9A-9B after inflation;

FIG. 11A shows an illustrative internal balloon sheath with a non-inlineballoon sleeve according to an embodiment of the present disclosure;

FIG. 11B shows an isometric view of the proximal end of the internalballoon sheath of FIG. 11A;

FIG. 12A shows a radial cross section of the internal balloon sheath ofFIGS. 11A-11B prior to inflation;

FIG. 12B shows a radial cross section of the internal balloon sheath ofFIGS. 11A-11B after inflation;

FIG. 13 shows an illustrative expandable internal balloon sheath with ainline balloon sleeve according to an embodiment of the presentdisclosure where the balloon and sheath are specifically designed toallow for local expansion of the sheath;

FIG. 14 shows an illustrative flowchart of a method of fabricating aninternal balloon sheath according to an embodiment of the presentdisclosure; and

FIG. 15 shows an illustrative flowchart of a method of using an internalballoon sheath according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

To provide an overall understanding of the devices and methods describedherein, certain illustrative embodiments will be described. Although theembodiments and features described herein are specifically described foruse in connection with internal balloon sheaths for use in intravascularprocedures involving catheter based ventricular assist devices, it willbe understood that all the components and other features outlined belowmay be combined with one another in any suitable manner and may beadapted and applied to other types of procedures requiring an internalballoon sheath.

The devices and methods described herein relate to an internal balloonsheath that comprises a tubular sheath body and an inflatable balloon.The tubular sheath body comprises a longitudinal axis, an open proximalend, an open distal end, an outer surface and an inner surface, theinner surface defining a lumen between the proximal and distal ends forpassage of a catheter device. The inflatable balloon is disposed withinthe lumen and is configured to occupy a longitudinal space in the lumenbetween the inner surface of the sheath body and the catheter devicewhen the catheter device is disposed within the sheath and the balloonis inflated, and fluidically seal the lumen.

Such a sheath prevents ingress of fluid after the balloon has beeninflated thereby preventing the stagnation of blood and clotting withinthe lumen of the sheath when the sheath is positioned within thevasculature of the patient. As the lumen within the sheath is sealedfrom the arteriotomy of the sheath, there is no need for the provisionof a flow of irrigation fluid through the lumen of the sheath, therebysimplifying the sheath delivery system. Further, the inflated balloonforms an interference fit between the external surface of the catheterdevice and the inner surface of the sheath, thereby fixing or lockingthe position of the catheter device during use. This does away with anybulky and cumbersome fixation techniques that would be otherwiseattached to the surface of the patient's skin. Additionally, as theinflatable balloon takes up any space between the catheter body and thesheath, the internal balloon sheath can be used with any size ofcatheter as the balloon appropriately occupies any difference indimension within the sheath.

In some embodiments the internal balloon may be attached to at least aportion of the inner surface of the sheath body. Here the internalballoon may be attached to the inner surface of the distal end of thesheath body. Alternatively, the internal balloon may span the entirelength of the sheath body and be attached to a plurality of attachmentpoints on the inner surface of the sheath body. In certain embodiments,the balloon may be an inline radially symmetric balloon which iscoaxially arranged with the sheath body such that the catheter devicetraverses through the balloon. In other embodiments, the balloon may bean asymmetric balloon. When inflated, the balloon forms an interferencefit with the sheath and the catheter body in which the balloon gripsonto the catheter thereby locking it in position.

In other embodiments the internal balloon may be attached to a balloonsleeve external to the sheath body. The sleeve may be arranged to have atight fit over the catheter of the medical device while being slideablethereon. The sleeve may be configured such that it can be slid about thecatheter and positioned within the lumen of the sheath. The balloon maybe attached to the external surface of the distal end of the sleeve.Alternatively, the balloon may span the entire length of the sleeve andbe attached to a plurality of attachment points on the external surfaceof the sleeve. In certain embodiments, the balloon may be an inlineradially symmetric balloon which is coaxially arranged with the sleevesuch that the catheter device traverses through the sleeve. In otherembodiments, the balloon may be an asymmetric balloon. When inflated,the balloon forms an interference fit with the sheath and the catheterbody in which the balloon grips onto the catheter thereby locking it inposition. In other embodiments, the balloon sleeve is positionedparallel to the catheter of the medical device, thereby not requiringthe medical device to be threaded through the balloon sleeve.

FIG. 1 shows a conventional sheath delivery system 100 for positioning acatheter device 140 in a blood vessel of a patient. Depicted in FIG. 1is a sheath 120 after it has been inserted through the skin 110 and intothe arteriotomy 112 of the patient. The sheath 120 is positioned in thevessel, such as a femoral artery 114, through which blood flows 116. Thesheath 120 facilitates the insertion of a catheter device 140 into theartery 114. The catheter device 140 may comprise a ventricular assistdevice such as a percutaneous pump. An example of such a percutaneouspump is the Impella 2.5™ pump system from Abiomed, Inc. of Danvers,Mass. Such pumps generally comprise a catheter body with a pump head ata distal end of the catheter body (not shown) and a handle at a proximalend of the catheter body (not shown). In most situations the pump headwould have a larger diameter than the diameter of the catheter body. Itwill be understood that while a percutaneous heart pump is describedherein, any other percutaneous or intravascular medical device can beused in conjunction with the present disclosure. The proximal end ofsheath 140 may be coupled to a hub 130.

In order to facilitate traversal of the catheter device through thesheath 100, the inner diameter d_(shi) of the sheath 120 is configuredto be equal to or larger than an outer diameter d_(catho) of the largestportion of the catheter device, i.e. d_(shi)≥d_(catho). In the case ofthe Imeplla 2.5™ pump system as exemplified in the foregoing, thelargest portion of the device is the pump head. After the pump headpasses through the sheath body 120, a space 128 exists between the innersurface 126 of the sheath 120 and the outer surface of the catheterdevice 140, as depicted in FIG. 2. This space 128 exists due to thedifference in the inner diameter of the sheath d_(shi) and the outerdiameter of the catheter body &who, as shown in FIG. 2. Such a spacefacilitates blood ingress within the sheath 120 while the sheath body isstill in the arteriotomy of the patient. As the space may not haveflowing fluids within it, stagnation of blood is likely to occur whichresults in the formation of clots 118, 119 in the space 128 of thesheath body 120, as illustrated in FIG. 3.

Such clot formation complicates intravascular medical procedures as theymay be accidentally dislodged from the sheath and freely move with theblood in the vessel, embolizing downstream (such as, for example, intodistal limb, up to right heart and lungs, etc.). Additionally, in someinstances clot formation can increase likelihood of blocking the bloodflow through the vessel. Further, once a clot begins to form it cancontinue to increase in size and block the lumen of the vessel. In somecases, to minimize clot formation, the sheath delivery system isprovided with a flow of irrigation fluid that is fed into the lumen ofthe sheath 120. This flow may be provided to the lumen continuously orat a predetermined frequency, which complicates the sheath deliverysystem as an additional control and monitoring mechanism for suchirrigation needs to be employed. Further, when the catheter device 140is deployed the proximal end of the device may be attached to the hub130 by tape or sutures. Such fixation may not ensure that the portion ofthe device within the patient's arteriotomy will not move. Additionally,such external fixation may be bulky and cumbersome, and may come looseas the patient moves.

FIG. 4 shows an expanded view of an internal balloon sheath 400according to an embodiment of the present disclosure. The sheath 400 issuitable for insertion into the arteriotomy of a patient, such as thefemoral artery. The sheath 400 comprises a sheath body 402 having aninner surface 404 and extending along a longitudinal axis 406. Thesheath body 402 comprises a lumen 408 of diameter d that extends alongthe longitudinal axis 406. In certain embodiments, the sheath body 402may be tubular with a circular cross section, however the sheath body402 may be of any shape and configuration. The sheath body 402 has aninternal diameter of d_(shi) and is suitable for introducing anintravascular medical device 420 into a vessel of the patient. Aspreviously mentioned, the medical device 420 may be a catheter baseddevice such as a percutaneous pump. An example of such a percutaneouspump is the Impella 2.5™ pump system from Abiomed, Inc. of Danvers,Mass. Such pumps generally comprise a catheter body 422 with a pump head424 at a distal end of the catheter body. In most situations the pumphead 424 has a larger diameter d_(catho) than the diameter of thecatheter body d_(catho). It will be understood that while a percutaneousheart pump is described herein, any other percutaneous or intravascularmedical device can be used in conjunction with the present disclosure.

Once the sheath 400 is in the correct position in the vessel, themedical device 420 is deployed from the distal end 403 of the sheathbody 402. In order for the medical device 420 to emerge from the sheath400, the internal diameter of the sheath body 402 is configured to be atleast equal to the diameter of the pump head 424, i.e.d_(shi)≥d_(catho). However this means that once the medical device 420is deployed into the vessel, the difference between the internaldiameter d_(shi) of the sheath body 402 and the external diameter of thecatheter body d_(catho) leads to a space developing that may result inthe formation of clots, as described in the foregoing.

According to an embodiment of the present disclosure, an inflatableballoon 410 is positioned in the lumen 408 of the sheath body 402. Insome embodiments, the balloon 410 may be positioned at the distal end403 of the sheath body 402. In the embodiments the balloon 410 may bepositioned elsewhere along the sheath body 402. In further embodiments,the balloon 410 may extend along the entire length of the sheath body402.

The balloon 410 is configured such that it is able to assume two statesand transition therebetween: a first state in which it is deflated, anda second state in which it is inflated. In the first state the balloon410 does not come into contact with the catheter body 422 of the medicaldevice 420, while in the second state the balloon 420 contacts thecatheter body 433 of the medical device 420. In order to transition fromthe first state, in which the balloon 410 is deflated, to the secondstate, in which the balloon 410 is inflated, a fluid is supplied to theballoon 410. In some embodiments, the fluid may be air, saline or water,for example, however any biocompatible fluid may be used to inflate theballoon 410. Such fluid may be supplied to the balloon via a fluid lumenwhich will be described in detail in the following sections. When theballoon 410 is inflated, it reduces the diameter of the lumen 408 suchthat the opening in the sheath body 402 is less than the diameter of thecatheter body 422 of the medical device 420, i.e. in the second stated<d_(catho). As the balloon is inflated (with saline or air) it fillsthe void/space between the catheter body 422 and inner surface 404 ofthe sheath thereby preventing blood ingress, stagnation, and clotting.It should be noted that during use, after the catheter device ispositioned in the arteriotomy of the patient, the lumen 408 of thesheath 400 may be first flushed with an irrigation fluid prior toinflation of the balloon 410. This removes any blood ingress that mayhave accumulated while the sheath 400 or the catheter device was beingpositioned.

In the second state the inflated balloon 410 comes into contact with thecatheter body 422 of the medical device 420 and exerts a compressiveforce on the medical device 420. Additionally, in the second state,frictional forces between the balloon 410 and the catheter body 422along the length of the catheter-balloon interface assist in thefixation of the position of the catheter body 422 relative to the sheath400. In some embodiments (when the balloon 410 is not attached to thesheath 400, as will be described below), frictional forces between theballoon 410 and the inner surface 404 of the sheath body 402 along theballoon-sheath interface also assist in fixating the location of thecatheter body 422 relative to the sheath 400.

While FIG. 4 shows an axially symmetric balloon 410, it will beappreciated that the balloon 410 can be of any shape or configuration.For example, the balloon 410 may be axially symmetric (as depicted inFIG. 4) in which it has a circular ring shape aligned about thelongitudinal axis 406 of the sheath 400. In such a configuration, whenthe balloon 410 is inflated, it exerts a radial compressive force on thecatheter body 422 from all directions about the longitudinal axis 406,thereby effectively gripping the catheter body 422 and locking it inposition. In other embodiments, the balloon 410 may be asymmetric aboutthe longitudinal axis 406 of the sheath 400. For example, the balloon410 may be positioned on one side of the longitudinal axis 406 of thesheath 400. In such configurations, when the balloon 410 is inflated andassumes the second state, it exerts a compressive force on the catheterbody 422 from one general direction. When that happens, the compressiveforce from the balloon 410 effectively pins the catheter body 422against the inner surface 404 of the sheath body 402 and locks itsposition. It will be understood that when the balloon 410 is in thesecond state, the balloon 410 prevents any axial or radial translationof the medical device 420, thereby locking it in a fixed position.

FIG. 5A illustrates an exemplary internal balloon sheath 500 accordingto an embodiment of the present disclosure. It will be understood thatthe internal balloon sheath 500 has similar features to sheath 400 ofFIG. 4 as described in the foregoing. Sheath 500 has a lumen for thepassage of an intravascular medical device, the catheter end 505 ofwhich is shown in FIG. 5A. Sheath 500 comprises a sheath body 510 havinga distal end 512 and a proximal end 514. Sheath 500 also comprises aninflatable balloon 515 positioned within the lumen of the sheath 500 andlocated at the distal end 512 of the sheath body 510. In FIG. 5A, theinflatable balloon 515 has a fixed length and does not span the entirelength of the sheath body 510. In some embodiments, the balloon 515 maybe positioned at other locations along the sheath body 510. Further, incertain embodiments of the present disclosure, balloon 515 may beattached to the inner walls of the sheath body 510, as will be describedin the following sections. Alternatively, the balloon 510 may bepositioned within the sheath 500 by the insertion of a balloon sleeveinto the lumen of the sheath body 510, as will be described in thefollowing sections.

FIG. 5B illustrates another exemplary internal balloon sheath 550according to an embodiment of the present disclosure. It will beunderstood that the internal balloon sheath 550 has similar features tosheath 500 of FIG. 5A as described in the foregoing. Sheath 550 has alumen for the passage of an intravascular medical device, the catheterend 555 of which is shown in FIG. 5B. As with sheath 500, sheath 550comprises a sheath body 560 having a distal end 562 and a proximal end564. However, in FIG. 5B, sheath 550 comprises an inflatable balloon 565positioned within the lumen of the sheath 500, that spans the entirelength of the sheath body 560. In certain embodiments of the presentdisclosure, balloon 565 may be attached to the inner walls of the sheathbody 560, as will be described in the following sections. Alternatively,the balloon 560 may be positioned within the sheath 550 by the insertionof a balloon sleeve into the lumen of the sheath body 560, as will bedescribed in the following sections.

According to some embodiments of the present disclosure, the balloons510, 560 in FIGS. 5A and 5B may be axially symmetric. In otherembodiments, the balloons 510, 560 may be asymmetric about thelongitudinal axis of the sheath body.

As shown in FIG. 5A, the proximal end 514 of the sheath body 510 may becoupled to a hub 520. Hub 520 serves as a handle which the physician cangrip while positioning the sheath 500 into the vasculature of thepatient. The hub may also have features to facilitate fixation of thehub to the skin of the patient once the sheath 500 has been positionedin the vasculature of the patient. Such fixation may be via sutures ortape. Additionally, the hub 520 may have at least one sideport 525, 530.Each sideport may be connected to a flexible tube 526, 531 as shown inFIG. 5A, and, optionally, a two-way or three-way stopcock. Each sideportmay be in fluid communication with the lumen of the sheath body 510. Insome embodiments, the sideport may be in fluid communication withadditional lumens in the sheath body 510, such as, for example, andinflation lumen as will be described in the following sections. In theembodiment of FIG. 5A, sideport 525 is in fluid communication with thelumen of the sheath body 510, while sideport 530 is in fluidcommunication with the inflatable balloon 515. Sideport 520 mayconnected to tube 526 such that irrigation fluid can be used to flushthe lumen of the sheath body 510 prior to inflation of the balloon 515.

Flushing the lumen prior to inflation of the balloon 515 removes anystagnation of blood which may have collected during insertion of thesheath into the arteriotomy of the patient. Sideport 530 may connectedto tube 531 such that inflation fluid can be used to inflate the balloon515 (described below). In some embodiments, sideport 530 may be in fluidcommunication with the balloon 515 via a fluid lumen formed in thesheath body 510, or via internal tubing that connects the source ofinflation fluid to the balloon 515. It should be noted that in the caseof FIG. 5B in which the balloon 565 spans the length of the sheath body560, there is no need for an inflation lumen within the walls of thesheath body as the proximal end of the balloon 565 may be in directfluid communication with the inflation port on the hub.

Once in sheath 500 and hub 520 are in position, the physician may attacha saline syringe and/or pull vacuum to the sideport(s) 525, 530 todeliver fluid through the sideport up the shaft of the sheath (in thewall of the sheath body, for example, as will be described in thefollowing sections) and into the inside of the balloon. Once the balloon515 is inflated the physician could shut off the stopcock on thesideport to lock the volume in place.

Returning to the embodiment in FIG. 4, the balloon 410 may be attachedto the inner surface 404 of the sheath body 402 and inflated anddeflated therefrom. Such attachment is implemented via a heat or solventbond. This bond is critical to ensure the balloon 410 does not rupture,during inflation, for example. In certain embodiments, the inner surface404 of the sheath body 402 may be pretreated with plasma activation orcoronary treatment to improve the likelihood of bonding the balloon 410to the sheath body 402. In some embodiments, the balloon 410 may belocated at a specific position on the sheath body 402. In suchembodiments, the point of attachment of the balloon 410 may be local tothe position of the balloon in the sheath 400. For example, for balloons410 that are positioned at the distal end 403 of the sheath body 402,the point of attachment of the balloon 410 to the inner surface 404 ofthe sheath body 402 is at the locale of the distal end 403 of the sheathbody 402.

In other embodiments, the balloon 410 may extend along the length of thesheath body 402. In such configurations, the balloon 410 may be attachedto the inner surface 404 of the sheath body 402, along the entire lengthof balloon 410. In other configurations, the balloon 410 may only beattached to the inner surface 404 of the sheath body 402 at certainpoints, such as, for example, the proximal and/or distal ends of thesheath body 402. In other embodiments, the balloon 410 may not beattached to the inner surface 404 of the sheath body 402. Instead, theballoon 410 may be positioned in the lumen 408 of the sheath body 402using a balloon sleeve, which will be described in the followingsections.

As mentioned in the foregoing, and with respect to the embodimentdepicted in FIG. 4, when in the first state, the balloon 410 is notinflated with fluid and does not come into contact with the catheterbody 422. According to an embodiment of the present disclosure, theballoon 410 may be configured to be compliant whereby the balloon 410sits flush and tight against a surface within the sheath 400 when in thefirst state. In some embodiments, this surface may be the inner wall 404of the sheath body 402. In other embodiments, the surface on which thecompliant balloon is attached may be an additional balloon sleeve (aswill be detailed in the following sections). The compliant balloon 410does not have excess balloon material when deflated and therefore allowsfor the unimpeded insertion and removal of medical devices 420 withinthe lumen 408 of the sheath body 402. Such compliant balloons may beeasier to fabricate and process as there is no excess balloon materialto manage during bonding of the balloon 410 to the inner surface 404 ofthe sheath body 402. When the compliant balloon 410 is inflated, theballoon material is elastically deformed by pressure from the inflatingfluid (which, in turn, may be delivered to the balloon 410 via asyringe, for example) causing it to seal against the catheter body 422,thereby closing off the lumen to entrants from the arteriotomy (such as,for example, blood and clots).

In other embodiments, the balloon 410 may be configured to benon-compliant where the balloon is attached to a surface within thesheath 400 when in the first state. In some embodiments, this surfacemay be the inner wall 404 of the sheath body 402. In other embodiments,the surface on which the compliant balloon is attached may be anadditional balloon sleeve (as will be detailed in the followingsections). The non-compliant balloon 410 material sits within the lumen408 of the sheath 400 when deflated (shown in FIGS. 6-8, and asdescribed in the following sections). Non-compliant balloons may be usedso that a fixed volume of fluid will always yield appropriate andpredictable inflation characteristics. In some embodiments, a fixedvolume syringe containing the inflation fluid may be provided with thesheath 400 to ensure the correct fluid volume of fluid is provided tothe balloon 410 each time the balloon 410 is inflated. In certainembodiments, a syringe (and, optionally, a fixed volume syringe) may beprovided with any of the internal balloon sheaths described in thisdisclosure, in a sheath kit.

With all the internal balloon sheaths of the present disclosure, it willbe understood that the lumen of the internal balloon sheath is flushedwith irrigation fluid to remove any blood ingress that may have occurredwhile positioning the sheath in the arteriotomy of the patient. Afterflushing the lumen, the balloon is inflated. Once the balloon isinflated, the lumen within the sheath body is sealed from thearteriotomy of the patient. It will be understood throughout thisdisclosure that ‘seal’ is to be taken to mean substantially sealing of alumen so as to eliminate fluid flow of any amount that would enableformation of clots. Thus, unlike conventional introducer sheaths, thepresent disclosure does away with the need for a constant flow ofirrigation fluid to flush the sheath lumen during treatment. Further, asthe balloon expands so as to seal the lumen via an interference fit withthe catheter of the medical device, the sheath can be used with anydiameter catheter, so long as the internal diameter of the sheath bodyis larger than the external diameter of the most distal end of thecatheter device.

FIG. 6 illustrates an axial cross section of a distal section of aninternal balloon sheath 600 according to an embodiment of the presentdisclosure. As in the embodiments described in the foregoing, sheath 600comprises a sheath body 610 having an inner surface 615 which defines alumen 620 for the passage of an intravascular medical device having acatheter body 630. An inflatable balloon 640 is positioned at the distalend 612 of the sheath body 610. The balloon 640 may be compliant ornon-compliant, and may be axially symmetric about the longitudinal axis605 of the sheath body 610, or asymmetric, the configurations of whichhave been described in the foregoing.

In some embodiments, in order to inflate distally positioned balloons,such as balloon 640, sheath 600 may also be provided with an inflationlumen 650 within the walls of the sheath body 610. Such an inflationlumen 650 may extend from the distal end 612 of the sheath body 610along the length of the sheath 600 to the proximal end (not shown). Theproximal end of the sheath 600 may be coupled to a hub (similar to thatshown in FIGS. 5A and 5B). The inflation lumen 650 is in fluidcommunication with the interior of the balloon 640 via an opening 655(or radial lumen 655) formed in the wall of the sheath body 610, at theinterface between the balloon 640 and the inner surface 615 of thesheath body 610. In some embodiments, balloon 640 may be attached to theinner surface 615 of the sheath body 610 via a heat or solvent bond, asalso described in the foregoing. These bonds are critical to ensure thatthe balloon 640 does not rupture. In certain embodiments, the sheathbody 610 may comprise a plurality of lumens similar to lumen 650 forother purposes, such as, for example, localized irrigation and flushing,or for the passage of a guidewire.

FIG. 7 shows a cross section 700 of sheath 600 taken about the line X-X′in FIG. 6, showing the inflation lumen 650 formed in the wall of thesheath body 610. In FIG. 7 the balloon 640 is shown as a non-compliantaxially symmetric balloon whereby the balloon material resides in thelumen 620 of the sheath body 610 when in the deflated state. However, asmentioned in the foregoing, any type of balloon (compliant,non-compliant, axially symmetric, asymmetric) may be used in conjunctionwith the embodiments of the present disclosure.

Inflation fluid is provided to the inflation lumen 650 at the hub from asyringe, for example, which then forces the fluid 652 into the inflationlumen 650, through the opening 655 and into the balloon 640 to inflateit. According to embodiments of the present disclosure, inflation fluidsmay comprise any biocompatible fluid such as, but not limited to, air,water and saline, for example. As mentioned in the foregoing, when theballoon 640 is inflated, it reduces the diameter of the lumen 620 suchthat the opening in the sheath body 610 is less than the diameter of thecatheter body 630 of the medical device. As the balloon is inflated itfills the space between the catheter body 630 and inner surface 615 ofthe sheath 600 thereby preventing blood ingress, stagnation, andclotting. Once fully inflated, the balloon 640 comes into contact withthe catheter body 630 of the medical device and exerts a compressiveforce on the catheter body 630. Frictional forces between the balloon640 and the catheter body 630 along the length of the catheter-ballooninterface may also assist in the fixation of the position of thecatheter body 630 relative to the sheath 600. In some embodiments (whenthe balloon is not attached to the inner surface of the sheath, as willbe described below, for example), frictional forces between the balloon640 and the inner surface 615 of the sheath body 610 along theballoon-sheath interface also assist in fixating the location of thecatheter body 630 relative to the sheath 600.

FIG. 8 illustrates an axial cross section of a section of an internalballoon sheath 800 according to an embodiment of the present disclosure.Sheath 800 comprises similar features to sheath 600 in FIG. 6, howeverthe balloon 820 in sheath 800 is positioned along the sheath body 810and not at the distal end as in FIG. 6. In FIG. 8 the balloon 820 isshown as non-compliant (and in the deflated state), however it will beunderstood that the balloon 820 may be configured in any manner asdescribed in the foregoing. Balloon 820 is attached to the inner surface815 of the sheath body 810 with a heat or solvent bond at locationsdistal and proximal to the opening 835. As described in relation tosheath 600, opening 835 fluidically connects the inflation lumen 830 tothe balloon 820 for the inflation thereof. These bonds are critical toensure the balloon does not rupture. It will be understood that theconfiguration depicted in the cross-section of FIG. 8 may vary dependingat least on (i) where the balloon 820 is located along the length of thesheath body 810, (ii) how the ends of the balloon 820 are affixed to theinner walls of the sheath body 810, and (iii) the location of theopening 835 relative to the length of the balloon 820. In certainembodiments in which the balloon spans the entire length of the sheathbody, the balloon may be inflated directly from the hub without the needfor an inflation lumen in the sheath body.

In some embodiments, the inflation lumens as described in with respectto FIGS. 6-8 may be formed in the sheath body by using a mandrel duringlamination and reflow of the sheath body. The mandrel does not melt intothe layers comprising the sheath body 610, and so can be extracted afterreflow thereby leaving the inflation lumen for the passage of inflationfluid to the balloon. The opening that fluidically connects theinflation lumen to the balloon may be formed using a similar processwhereby a radially oriented mandrel is positioned in the sheath bodybefore reflow, and subsequently removed. Alternatively, the opening canbe punched out of the sheath body after the inflation lumen is formed.Notwithstanding, it will be appreciated that the formation of theinflation lumen and opening may involve complex processing due to thedimensions and tolerances involved.

FIGS. 9A-9B illustrate an exemplary internal balloon sheath 900according to an embodiment of the present disclosure. Internal balloonsheath 900 comprises a balloon sleeve 910 and an access sheath 920, theballoon sleeve 910 comprising an in-line sleeve that is insertable intothe lumen of the access sheath 920. Internal balloon sheath 900 isconfigured for the passage of a catheter based medical device 930therethrough. The balloon sleeve 910 comprises a sleeve body 912 with alumen 911 running therethrough. The distal end of the balloon sleeve 910may comprise an inflatable balloon 915. Balloon 915 may be attached tothe external surface of the distal end of the balloon sleeve 910 usingany the attachment means as described in the foregoing. Any type ofballoon (compliant, non-compliant, axially symmetric, asymmetric, asdescribed in the foregoing) may be used in conjunction with theembodiments of the present disclosure.

The proximal end of the balloon sleeve 910 may comprise a valve 913 thatseals the lumen 911 of the balloon sleeve 910 against the ingress ofexternal fluids. In some embodiments the valve 913 may comprise ahaemostatic valve, for example. The proximal end of the balloon sleeve910 may also comprise a side port 914 that is in fluid communicationwith the lumen 911 and/or the balloon 915. In certain embodiments, theside port 914 may be in fluid communication with the balloon 915 via aninflation lumen formed in the sleeve body 912, such as inflation lumen650 shown in FIG. 6. Side port 914 is similar to side ports 525, 530 asdiscussed in the foregoing with respect to FIG. 5A. In some embodiments,a plurality of side ports may be present on the balloon sleeve 910.Additionally, in certain embodiments, the proximal end of the side port914 may be coupled to a connector to prevent the backflow of fluid, suchas, for example, a Tuohy-Borst adaptor.

In some embodiments, the balloon sleeve 910 may be axially aligned withthe catheter 930 of the medical device such that the sleeve 910 isin-line with the catheter 930. In this configuration, the balloon sleeve910 is co-axially arranged around the catheter 930 of the medicaldevice, as depicted in FIG. 9A. The balloon sleeve 910 may be tightlyfit around the catheter 930, while allowing the sleeve 910 to be movedor translated along the catheter 930 into the access sheath 920. Incertain embodiments, the catheter 930 of the medical device may bepre-threaded through the lumen 911 of the balloon sleeve prior to use.In some embodiments, the catheter of the medical device may bemanufactured with the balloon sleeve 910 coaxially arranged around thecatheter 930.

The access sheath 920 is similar to the sheaths that have been describedin the foregoing in relation to FIGS. 4-8. Access sheath 920 comprises asheath body 922 having a proximal end 924, a distal end 926 and a lumen928 running between the proximal and distal ends. The proximal end 924may be coupled to a hub 940. Hub 940 is similar to hub 520 depicted inFIG. 5A, and may have at least one side port 942 positioned thereon. Theside port 942 may be in fluid communication with the lumen 928 of theaccess sheath 922 for irrigation and flushing, for example.

As previously described, the distal end of intravascular medical devicesusually has the largest diameter compared to the catheter body. Thesheath body 922 is configured such that the diameter of the lumen 928 islarge enough to allow the distal end of the medical device to passthrough the lumen 928. Additionally, the lumen 928 may be configuredsuch that it allows the balloon sleeve 910 to pass therethrough, i.e.the lumen 928 has a diameter that is larger than the external diameterof the balloon sleeve 910. In certain embodiments of the presentdisclosure, the diameter of the lumen 928 is such that a space 950develops between the external surface of the balloon sleeve body 912 andthe internal surface of the sheath body 922 when the balloon sleeve 910is inserted into the lumen 928 of the access sheath 920. This space issimilar to that as described in the foregoing in relation to FIG. 4. Insome embodiments, the axial length of the balloon sleeve 910 may belarger than the axial length of the access sleeve 920. This ensures thatat least a portion of the proximal end of the balloon sleeve 910 sticksout of the hub 940 of the access sheath 920 when the balloon sleeve 910is inserted into the access sheath 920. This allows for the proximal endof the balloon sleeve 910 (and the side ports attached thereto) to beeasily accessed, for inflation of the balloon 915, or example.

FIG. 9B shows the cross section of the internal balloon sheath 900 oncethe balloon sleeve 910 is moved along the catheter 930 of the medicaldevice and into the lumen 928 of the access sheath 920. The balloonsleeve 910 would be positioned within the access sheath 920 after thelumen 928 is flushed with an irrigation fluid (e.g. saline or water) viaside port 942. In FIG. 9B, the balloon 915 is shown as being in theinflated state. The balloon 915 may be inflated with an inflation fluidprovided via side lumen 914. While not shown in FIG. 9A, this may be viaan inflation lumen formed within the balloon sleeve body 912. Asmentioned in the foregoing, when the balloon 915 is inflated, theballoon material may be elastically deformed by the pressure from theinflating fluid (which, in turn, may be delivered to the balloon 915 viaa syringe, for example) causing it to seal against the catheter body930, thereby closing off the lumen to entrants from the arteriotomy(such as, for example, blood and clots). When the balloon 915 isinflated, it exerts a radially expansive force on the inner surface ofthe access sheath body 922 from all directions, thereby effectivelyfixing the position of the balloon sleeve 910 relative to the accesssheath 920. In some embodiments, the access sheath 920 may be made of amaterial that deforms under the influence of such compressive forces, aswill be described in relation to FIG. 13 in the following section.Additionally, when the balloon 915 is inflated, it also exerts aradially compressive force on the catheter body 930 from all directionsabout the catheter, thereby effectively gripping the catheter body 930and locking it in position.

FIG. 10A shows a cross section 1000 of the in-line internal balloonsheath 900 taken about the line Y-Y′ in FIG. 9B before balloon 915 isinflated. FIG. 10A shows the balloon sleeve 910 coaxially arrangedaround the catheter body 930 of the medical device. As mentioned, theballoon sleeve 910 is tightly fit around the catheter body 930 whilebeing slidable on the catheter body 930. The balloon sleeve 910 isinserted into the lumen 928 of the access sheath 922. As previouslydescribed, in some embodiments, the balloon sleeve 912 may comprise aninflation lumen that fluidically connects an inflation port 914 on theproximal end of the balloon sleeve 910 to the balloon 915 for inflationof the balloon. FIG. 10A shows the space 950 between the externalsurface of the balloon sleeve body 912 and the internal surface of thesheath body 922 when the balloon sleeve 910 is inserted into the lumen928 of the access sheath 920. While the balloon 915 is illustrated asbeing coaxially arranged with the balloon sleeve 912, any orientation ofthe balloon 915 with respect to the balloon sleeve body 912 may be used.For example, the balloon 915 may be positioned on at least one portionof the external surface of the balloon sleeve body 915.

FIG. 10B shows a cross section 1050 of the in-line internal balloonsheath 900 taken about the line Y-Y′ in FIG. 9B after balloon 915 isinflated. When the balloon 915 is inflated, the balloon material mayelastically deform by the pressure from the inflating fluid (which, inturn, may be delivered to the balloon 915 via a syringe, for example)causing it to seal against the inner surface of the access sheath 922.As can be seen, the balloon 915 occupies the space 950 upon inflation,thereby preventing fluid ingress (such as, for example, blood and clots)into the lumen 928 of the access sheath 920. It will be understoodthroughout this disclosure that ‘seal’ is to be taken to meansubstantially sealing of a lumen so as to eliminate fluid flow of anyamount that would enable formation of clots. When the balloon 915 isinflated, it exerts a radially expansive force on the inner surface ofthe access sheath body 922 from all directions, thereby effectivelyfixing the position of the balloon sleeve 910 relative to the accesssheath 920. In some embodiments, the access sheath 920 may be made of amaterial that deforms under the influence of such compressive forces, aswill be described in relation to FIG. 13 in the following section.Additionally, when the balloon 915 is inflated, it also exerts aradially compressive force on the catheter body 930 from all directionsabout the catheter, thereby effectively gripping the catheter body 930and locking it in position.

FIGS. 11A-11B illustrate an exemplary internal balloon sheath 1100according to an embodiment of the present disclosure. Internal balloonsheath 1100 comprises a balloon sleeve 1110 and an access sheath 1120.Unlike the balloon sleeve 910 in FIGS. 9A-9B, the balloon sleeve 1100shown in FIGS. 11A-11B is not positioned in-line with the catheter of amedical device. Balloon sleeve 1100 comprises a sleeve body 1112 havinga balloon 1115 located at the distal end 1113 thereof. In someembodiments, the balloon 1115 may be located at any point along thesleeve body 1112. The sleeve body 1112 may have a central lumen that isfluidically connected to the balloon 1115 for inflation. The balloon1115 may be oriented in any manner with respect to the balloon sleevebody 1112 may be used. For example, the balloon 1115 may besymmetrically arranged about the sleeve body 1112, or the balloon 1115may be asymmetrically arranged about the sleeve body 1112. Further,balloon 1115 may be attached to the external surface of the distal end1113 of the sleeve body 1112 using any of the attachment means asdescribed in the foregoing. Any type of balloon (compliant,non-compliant, axially symmetric, asymmetric, as described in theforegoing) may be used in conjunction with the embodiments of thepresent disclosure.

The proximal end of the balloon sleeve 1110 may be coupled to a sleevehub 1116, which, in turn, may be provided with at least one side port1117. The side port 1117 may be in fluid communication with the centrallumen in the sleeve body 1112 and/or the balloon 1115. As described inthe foregoing, the side port may be used as an inflation port to inflatethe balloon 1115 with an inflation fluid after the sheath 1100 ispositioned in the arteriotomy of the patient. Hub 1116 may also beprovided with a connector port 1118 for the coupling of an additionaladaptor to prevent the backflow of fluid, such as, for example aTuohy-Borst adaptor.

Access sheath 1120 is similar to access sheath 920 in FIG. 9A asdescribed in the foregoing. Access sheath 1120 comprises a sheath body1122 having a proximal end 1124, a distal end 1126 and a lumen 1128running between the proximal and distal ends. The proximal end 1122 maybe coupled to a hub 1140. Hub 1140 is similar to hub 520 depicted inFIG. 5A, and may have at least one side port 1142 positioned thereon.The side port 1142 may be in fluid communication with the lumen 1128 ofthe access sheath 1120 for irrigation and flushing the lumen 1128, forexample.

The sheath body 1120 is configured such that the diameter of the lumen1128 is large enough to allow the distal end of the medical device topass through. Additionally, the lumen 1128 is configured such that itallows both the balloon sleeve 1110 and the catheter body 1130 of themedical device to pass therethrough, i.e. the lumen 1128 has a diameterthat is larger than the combined external diameters of both the sleevebody 1112 and the catheter body 1130. In certain embodiments of thepresent disclosure, the diameter of the lumen 1128 is such that a space1150 develops between the external surface of the balloon sleeve body1112, the external surface of the catheter bodyl130, and the internalsurface of the sheath body 1122 when the catheter 1130 of the medicaldevice and the balloon sleeve 1110 are both inserted into the lumen 1128of the access sheath 1120 (see FIG. 12A, described below). This space issimilar to that as described in the foregoing in relation to FIG. 4.

In some embodiments, the axial length of the balloon sleeve 1110 may belarger than the axial length of the access sleeve 1120. This ensuresthat at least a portion of the proximal end of the balloon sleeve 1110sticks out of the hub 1140 of the access sheath 1120 when the balloonsleeve 1110 is inserted into the access sheath 1120, as shown in FIG.11B. This allows for the proximal end of the balloon sleeve 1110 (andthe side ports attached thereto) to be easily accessed, for inflation ofthe balloon 1115, or example.

FIG. 12A shows a cross section 1200 of the internal balloon sheath 1100taken about the line Z-Z′ in FIG. 11B before balloon 1115 is inflated.The balloon sleeve 1110 is inserted into the lumen 1128 of the accesssheath 1120, and comprises a sleeve body 1112 having an inflation lumenformed therethrough, the lumen being in fluid communication with theballoon 1115. In some embodiments, the balloon sleeve body 1112 maycomprise an inflation lumen that fluidically connects the inflation port1117 on the proximal end of the balloon sleeve 1112 to the balloon 1115for inflation of the balloon. FIG. 12A shows the space 1150 between theinternal surface of the sheath body 1120, the external surface of thecatheter body 1130 and the external surface of the balloon sleeve 1110,after the medical device and the balloon sleeve 1110 have been insertedinto the lumen 1128 of the access sheath 1120. While the balloon 1115 isillustrated as being concentrically arranged around the balloon sleevebody 1112, any orientation of the balloon 1115 with respect to theballoon sleeve body 1112 may be used. For example, the balloon 1115 maybe positioned on at least one portion of the external surface of theballoon sleeve body 1115.

FIG. 12B shows a cross section 1250 of the internal balloon sheath 1100taken about the line Z-Z′ in FIG. 11A after balloon 1115 is inflated.When the balloon 1115 is inflated, the balloon material may elasticallydeform by the pressure from the inflating fluid (which, in turn, may bedelivered to the balloon 1115 via a syringe, for example) causing it toseal against the catheter body 1130. As can be seen, the balloon 1115occupies the space 1150 upon inflation, thereby preventing fluid ingress(such as, for example, blood and clots) into the lumen 1128 of theaccess sheath 1120. It will be understood throughout this disclosurethat ‘seal’ is to be taken to mean substantially sealing of a lumen soas to eliminate fluid flow of any amount that would enable formation ofclots. When the balloon 1115 is inflated, it exerts a radially expansiveforce on the inner surface of the access sheath body 1122 from alldirections, thereby effectively fixing the position of the balloonsleeve 1110 relative to the access sheath 1120. Additionally, when theballoon 1115 is inflated, it exerts a radially compressive force on thecatheter body 1130 so as to pin the catheter body 1130 of the medicaldevice against the inner surface of the access sheath 1120, therebyeffectively gripping the catheter body 1130 and locking it in position.In some embodiments, the access sheath 1120 may be made of a materialthat deforms under the influence of such expansive forces, as will bedescribed in relation to FIG. 13 in the following section.

FIG. 13 illustrates an exemplary internal balloon sheath 1300 accordingto an embodiment of the present disclosure. Internal balloon sheath 1300comprises an inflatable balloon sleeve 1310 and an access sheath 1320.Balloon sleeve 1310 may be similar to balloon sleeves 910, 1110 asdescribed in the foregoing with respect to FIGS. 9-12. Sleeve 1310comprises a sleeve body 1311 having a proximal end 1312 and a distal end1313. An inflatable balloon 1315 may be attached to the distal end 1313of the outer surface of the sleeve body 1311. The proximal end 1312 maybe coupled to a hub 1316, which, in turn, may be provided with aninflation port 1314. Inflation port 1314 is configured to be in fluidcommunication with the 1315 such that inflation fluid input at theinflation port 1314 inflates the balloon 1315. In some embodiments, theinflation port 1314 may be fluidically connected to the balloon 1315 viaan inflation lumen formed in the walls of the sleeve body 1311.

The balloon 1315 may be oriented in any manner with respect to theballoon sleeve body 1311. For example, the balloon 1315 may besymmetrically arranged about the sleeve body 1311, or the balloon 1315may be asymmetrically arranged about the sleeve body 1311. Further,balloon 1315 may be attached to the external surface of the distal end1313 of the balloon sleeve 1310 using any of the attachment means asdescribed in the foregoing. Any type of balloon (compliant,non-compliant, axially symmetric, asymmetric, as described in theforegoing) may be used in conjunction with the embodiments of thepresent disclosure.

As with the balloon sleeve 1310, access sheath 1320 may be similar toaccess sheaths 920, 1120 as described in the foregoing with respect toFIGS. 9-12. Access sheath 1320 comprises a sheath body 1321 having aproximal end 1322, a distal end 1323 and a lumen 1324 running betweenthe proximal and distal ends. The proximal end 1322 may be coupled to ahub 1325. Hub 1325 may have at least one side port (not shown)positioned thereon which may be in fluid communication with the lumen1324 of the access sheath 1320 for irrigation and flushing the lumen,for example.

The sheath body 1321 is dimensioned such that the diameter of the lumen1324 is large enough to allow a distal end of the medical device to passthrough. Additionally, the lumen 1324 is configured such that it allowsthe balloon sleeve 1310 to pass through. In certain embodiments of thepresent disclosure, the diameter of the lumen 1324 is such that a spacedevelops between the external surface of the balloon sleeve body 1311and the internal surface of the sheath body 1321 when the balloon sleevebody 1311 (positioned in-line with the catheter 1330 of the medicaldevice) is inserted into the lumen 1324 of the access sheath 1320. WhileFIG. 13 depicts the balloon sleeve 1310 to be in-line with the catheter1330 of the medical device (such as in FIGS. 8-9), the balloon sleeve1310 may, alternatively, be adjacent the catheter 1330 of the medicaldevice (such as in FIGS. 10-11).

As described in the foregoing embodiments, when the balloon 1315 isinflated with fluid, the balloon occupies the aforementioned spacebetween the external surface of the balloon sleeve body 1311 and theinternal surface of the sheath body 1321, thereby sealing the lumen 1324from ingress of blood from the arteriotomy of the patient. In theembodiment depicted in FIG. 13, the sheath body 1321 is capable ofelastic deformation such that when the balloon 1315 expands in size, theexpansive force from the inflating balloon 1315 also causes the sheathbody 1321 adjacent the balloon to deform. This causes bulging in theaccess sheath 1320 which prevents axial movement of the internal balloonsheath 1300 after insertion into the patient. Thus, in addition tosutures or tape that fixes the location of the hub 1325 to the skin 1305of the patient, the bulge in the access sheath 1320 when the balloon1315 is inflated locks the position of the sheath 1300 thereby furthersecuring the sheath 1300 to the patient.

In all the embodiments described in the foregoing, the sheath maycomprise a rigid material. The rigid material may be a polyethylene (PE)or polyurethane (PU) material. In certain embodiments, the rigidmaterial may have an elastic modulus of about 40 ksi (285 MPa). Ksi is aunit of pressure, representing thousands of pounds per square inch. Insome embodiments the rigid material contains a radiopaque filler such asbismuth oxychloride or barium sulfate in concentrations of 5% to 40% byweight. In some embodiments, the rigid material may be any one of apolyether block amide (such as PEBAX or PebaSlix®), a polyethylenematerial, a polytetrafluoroethylene (PTFE) material, a high-densitypolyethylene (HDPE) material, a medium-density polyethylene (MDPE)material, a low-density polyethylene (LDPE) material, polyether etherketone (PEEK), a polyether block amide (such as PEBAX) and nylon. Incertain implementations, the rigid material is a crack-resistantmaterial. In some embodiments, the rigid material may also be a materialwith a low coefficient of friction. Additionally, in all the embodimentsdescribed in the foregoing, the hub may also comprise any one of theabove rigid materials. Generally the strength of the sheath is dependenton the modulus of the rigid material as well as the thickness of thesheath wall. For rigid materials having a lower elastic modulus, theresulting sheath will require a wall of greater thickness. Conversely,rigid materials having a higher modulus allows for a sheath having alower wall thickness.

In all the embodiments described in the foregoing, the sheath body maycomprise a coaxially layered structure as described in U.S. ProvisionalPatent Application No. 62/777,598, the contents of which are herebyincorporated by reference in entirety. Each layer of the structure maycomprise a different polymer. The layering of the polymers improves thestrength of the sheath while maintaining flexibility, which is ideal forapplication to intravascular applications as detailed in the presentdisclosure. The polymers may comprise any one of PEBAX® 7233SA, PEBAX®7033SA, PEBAX® 6333SA, PEBAX® 5533SA, PEBAX® 3533SA, and PEBAX® 2533SA.In other embodiments, the sheath may comprise various sections that aresequentially arranged, each section comprising a different polymer. Suchan arrangement provides for a varying mechanical strength along thelength of the sheath body. The polymers may comprise any of theaforementioned rigid materials. In certain embodiments, the sheath bodymay be reinforced with braids or coils to improve mechanical strength,these structures being constructed from wires made from any one of theaforementioned rigid materials. In some embodiments, the structure ofthe sheath body may be strengthened by laser cutting the tubular sheathbody with features that enhance its strength.

Further, in all the embodiments described in the foregoing, the balloonmay comprise a flexible material. The flexible material may comprise apolyethylene or polyurethane material with an elastic modulus of about40 ksi. In some embodiments the material may be any one of urethane,polyurethane, polyethylene, polypropylene, polyethylene terephthalate(PET), polyvinyl chloride (PVC), polyethylene, cross-linkedpolyethylene, a polyether block amide (PEBA), and nylon. In someembodiments, the balloon sleeve may also comprise a flexible material asdefined in the foregoing.

Additionally, in all the embodiments described in the foregoing, the hubmay comprise a rigid material. The rigid material may be a polyethyleneor polyurethane material with an elastic modulus of about 40 ksi. Insome implementations, the rigid material is any one of a high-densitypolyethylene (HDPE) material, a medium-density polyethylene (MDPE)material, a low-density polyethylene (LDPE) material, polyether etherketone (PEEK), and a polyether block amide (such as PEBAX). In certainimplementations, the rigid material is a crack-resistant material. Insome implementations, the rigid material may also be a material with alow coefficient of friction.

In all the embodiments described in the foregoing, a coating may beapplied to the balloon so as to reduce the friction during passage ofinterventional devices through the internal balloon sheath. In certainembodiments, the coating may be hydrophilic or hydrophobic. In someembodiments, the thickness of this coating may be varied to achievedesired inflation characteristics of the balloon. Additionally, in allthe embodiments described in the foregoing, the inner surface of thesheath may be pretreated to improve the likelihood of bonding with theballoon. Such pretreatment may include, but is not limited to, plasmaactivation or coronary treatment. Alternatively, or in addition to theaforementioned coatings, a coating may be applied to the catheter basedmedical device itself prior to insertion into the internal balloonsheath.

Additionally, in all the embodiments described in the foregoing, thesheath body may additionally comprise a distal tip made up of a softermaterial than that used for the sheath body, i.e. the distal tip maycomprise a material that has a lower elastic modulus than that of thematerial used for the sheath body. In some embodiments, the distal tipmay be beveled to aid with insertion of the sheath into the arteriotomyof the patient. Such distal tips can seal down on catheters of smallerdiameters. By sealing on the catheter, blood is prevented from enteringthe sheath body and clot. In certain embodiments the distal tip maycontain a radiopaque filler such as bismuth oxychloride or bariumsulfate in concentrations of 5% to 40% by weight.

FIG. 14 illustrates an exemplary method 1400 of fabricating an internalballoon sheath, such as any of the balloon sheaths as described in theforegoing description, according to an embodiment of the presentdisclosure. The method 1400 begins at step 1410 in which a sheath bodyis made available for fabrication. The sheath body may be provided byextrusion of lamination. As described in the foregoing, the sheath bodyhaving a longitudinal axis and comprising an open proximal end, an opendistal end, an outer surface and an inner surface, the inner surfacedefining a lumen between the proximal and distal ends. In someembodiments, the method may include the fabrication of a tubular sheath.In certain embodiments, the method may comprise the fabrication of asheath with a diameter that is larger than the external diameter of adistal end of catheter based intravascular medical device, such as, forexample, a heart pump, so as to allow the passage of the medical throughthe lumen of the sheath body.

In certain embodiments, the method may include the fabrication of asheath body that may comprise a coaxially laminated layered structure.Further, in some embodiments, the sheath body may comprise structuralreinforcements such as a coil or braid. Such layered and/or reinforcedbody structures enable the sheath to withstand larger pushing forces,such as those experienced during the positioning of the internal balloonsheath in the arteriotomy of the patient. In some embodiments, thestructure of the sheath body may be strengthened by laser cutting thetubular sheath body with features that enhance its strength. In certainembodiments, the inner surface of the sheath body may be pretreated (viaplasma activation or coronary treatment, for example) to improve thelikelihood of bonding with a balloon.

The method then continues to step 1420, in which an inflatable balloonis provided within the sheath body. In some embodiments, the balloon isprovided by extrusion or blow molding. In certain embodiments, themethod comprises attaching the balloon to the inner wall of the sheathbody where the balloon is contained within the inner diameter of thesheath body. In some embodiments, the method further comprisesattachment of the balloon to a balloon sleeve which is insertable intothe lumen of the sheath body. In some embodiments, the method comprisesthe attachment of a balloon that extends along the entire length of thesheath body. In other embodiments, the method comprises attachment of aballoon that only extends along a portion of the length of the sheathbody. In some embodiments, the method comprises the attachment of theballoon at only a portion of the inner surface of the sheath body, suchas, for example, the distal end of the sheath body. In otherembodiments, the method comprises attachment of the balloon to the innersurface of the sheath body (or the outer surface of the balloon sleeve)along the entire length of the balloon. Further, in some embodiments,the method comprises attachment of the balloon along the entirecircumference of the sheath body (or the balloon sleeve). In otherembodiments, the method comprises attachment of the balloon along atleast a portion of the circumference of the sheath body (or the balloonsleeve).

Additionally, in some embodiments, the method comprises the attachmentof a balloon that is in-line with (i.e. radially symmetrical about) thecatheter body of a medical device traversing through the lumen of thesheath. In other embodiments, the method comprises the attachment of aballoon that is radially asymmetrical about the catheter body of amedical device traversing through the lumen of the sheath.

FIG. 15 illustrates an exemplary method 1500 of using an internalballoon sheath, such as any of the balloon sheaths as described in theforegoing description, according to an embodiment of the presentdisclosure. The method 1500 begins at step 1510 in which an internalballoon sheath is positioned into the arteriotomy of the patient. Aspreviously mentioned, any of the sheaths described in the foregoing mayhave a tip formed on a patient proximate end of the sheath body. Such atip may be beveled to aid with insertion into the patient. In someembodiments, the sheath body may have a laminated structure that is ableto withstand large pushing forces, such as those used to insert thesheath into the patient, without kinking, bending or buckling. Incertain embodiments, a dilator may be inserted into the lumen of thesheath before insertion into the patient. The dilator assists withpositioning the sheath in regions of the patient's body which aredifficult to penetrate with the sheath alone. Once inserted, the dilatoris removed from the lumen of the sheath.

In step 1520, the catheter based medical device is inserted into thelumen of the sheath. The medical device is advanced into the lumen ofthe sheath body until it emerges from the distal tip of the sheath andis positioned in the arteriotomy of the patient. In some embodiments,the physician may manipulate the position of the medical device byholding onto a hub affixed to the proximal end of the catheter body ofthe medical device. Once in position, the catheter hub may be coupled tothe hub of the sheath located on the exterior surface of the patient.

In some embodiments, the sheath may comprise an internal balloonattached to the internal surface of the sheath body, as described in theforegoing. In other embodiments, the balloon may be located on anadditional balloon sleeve that is slidably arranged along the catheterbody of the medical device. Once the sheath is in position and themedial device is inserted into the arteriotomy of the patient, theballoon sleeve may be slid into position, along the catheter body. Theballoon sleeve is positioned between the internal surface of the sheathbody and the external surface of the catheter body. The variousconfigurations and attachments of the internal balloon to the sheathand/or the balloon sleeve that have been described in the foregoingdescription, while omitted here for brevity, are applicable to themethod 1500.

As described in the foregoing, a space may exist between the innersurface of the sheath body and the external surface of the catheterbody. In order to prevent stagnation and clotting during positioning ofthe medical device, the once the medical device is positioned in thearteriotomy of the patient, the method may optionally comprise theflushing of the lumen of the sheath body (and hence the space) with anirrigation fluid, such as, for example, saline or water. Such irrigationfluid may be provided to the lumen via an irrigation side portfluidically connected to the lumen, as described in the foregoing.

In step 1530, a balloon is inflated within the lumen of the sheath withan inflation fluid, thereby fluidically sealing the lumen, and the spacebetween the inner surface of the sheath body and the external surface ofthe catheter body. It will be understood throughout this disclosure that‘seal’ is to be taken to mean substantially sealing of a lumen so as toeliminate fluid flow of any amount that would enable formation of clots.Inflation fluids may include saline, air or water, for example. Suchinflation fluid may be provided to the balloon via an inflation sideport fluidically connected to the balloon, as described in theforegoing. In some embodiments an inflation lumen may be provided withinthe sheath body to deliver the inflation fluid to the balloon.

Once the balloon is inflated, the balloon forms an interference fit withthe inner surface of the sheath body and the external surface of thecatheter body, thereby also preventing any axial movement of thecatheter body. As such the balloon effectively locks the medical devicein place after the balloon is inflated. In certain embodiments,inflation of the balloon also causes the elastic deformation of thesheath body, whereby the sheath body adjacent the inflated balloonexpands into a bulge within the arteriotomy o the patient. Such a bulgewill further fix the position of the internal balloon sheath within thevasculature of the patient while the medical device is in use, therebysecuring it.

If desired, the different steps discussed herein may be performed in adifferent order and/or concurrently with each other. Furthermore, ifdesired, one or more of the above described steps may be optional or maybe combined.

The foregoing is merely illustrative of the principles of thedisclosure, and the devices and methods can be practiced by other thanthe described implementations, which are presented for purposes ofillustration and not of limitation. It is to be understood that thedevices and methods disclosed herein, while shown for use in manufactureof an internal balloon sheath, may be applied to other systems in whichsealable sheaths of a single diameter for insertion into the vasculatureof the patient are required during intravascular procedures.

Variations and modifications will occur to those of skill in the artafter reviewing this disclosure. The disclosed features may beimplemented, in any combination and subcombination (including multipledependent combinations and subcombinations), with one or more otherfeatures described herein. The various features described or illustratedabove, including any components thereof, may be combined or integratedin other systems. Moreover, certain features may be omitted or notimplemented.

Examples of changes, substitutions, and alterations are ascertainable byone skilled in the art and could be made without departing from thescope of the information disclosed herein. All references cited hereinare incorporated by reference in their entirety and made part of thisapplication.

Illustrative Embodiments

-   A1. A sheath for delivery of a catheter device through an    arteriotomy of a patient, the sheath comprising:

a tubular sheath body having a longitudinal axis, an open proximal end,an open distal end, an outer surface and an inner surface, the innersurface defining a lumen between the proximal and distal ends forpassage of a catheter device; and

an inflatable balloon disposed within the lumen and configured to:

occupy a longitudinal space in the lumen between the inner surface ofthe sheath body and the catheter device when the catheter device isdisposed within the sheath and the balloon is inflated, and

fluidically seal the lumen.

-   A2. The sheath according to A1, wherein the balloon forms an    interference fit between the catheter device and the inner surface    of the sheath body when inflated.-   A3. The sheath according to any of A1-A2, wherein the balloon is    positioned at least at the distal end of the sheath body.-   A4. The sheath according to any of A1-A3, wherein the balloon is    positioned along the entire length of the sheath body.-   A5. The sheath according to any of A1-A4, wherein the balloon is    attached to the inner surface of the sheath body.-   A6. The sheath according to A0, wherein the balloon is attached at    least at the distal end of the inner surface of the sheath body.-   A7. The sheath according to A0, wherein the balloon is attached    along the entire length of the inner surface of the sheath body.-   A8. The sheath according to any of A0-A0, wherein the balloon is    attached along at least a portion of the circumference of the sheath    body.-   A9. The sheath according to any of A0-A0, wherein the balloon is    attached along at least any of the following portions of the sheath    body: about 25%, about 50%, about 75%, about 100% of the inner    circumference of the sheath body.-   A10. The sheath according to any of A0-A0, wherein the inner surface    of the sheath body is pretreated to improve attachment of the    balloon to the inner surface of the sheath body.-   A11. The sheath according to any of A0-A0, wherein the balloon is    attached to the inner surface of the sheath body via heat or solvent    bond.-   A12. The sheath according to A0, wherein the inner surface of the    sheath body is pretreated via any one of: plasma activation and    coronary treatment.-   A13. The sheath according to any of A1-A12, wherein the balloon is    inflated via an inflation opening located on the inner surface of    the distal end of the sheath body.-   A14. The sheath according to A0, wherein the sheath body comprises    an inflation lumen that extends from the proximal end of the sheath    body to the inflation opening.-   A15. The sheath according to A0, wherein the inflation lumen is in    fluid communication with the inflation opening.-   A16. The sheath according to any of A0-A0, wherein the inflation    lumen extends along the length of the sheath body linearly or    curvilinearly.-   A17. The sheath according to any A0-A0, further comprising:

a balloon sleeve on which the inflatable balloon is attached, the sleevealigned in-line with the catheter device and configured to traverse thelumen of the sheath body.

-   A18. The sheath according to A0, wherein the proximal end of the    balloon sleeve comprises a hemostasis valve that seals with the    catheter device.-   A19. The sheath according to any of A0-A0, wherein the balloon    sleeve comprises an inflation lumen in fluid communication with the    balloon for inflation.-   A20. The sheath according to A0, wherein the proximal end of the    balloon sleeve comprises an inflation port in fluid communication    with the inflation lumen for inflation.-   A21. The sheath according to any A1-A0, wherein the proximal end of    the sheath body is coupled to an inflation port that is in fluid    communication with the balloon for inflation.-   A22. The sheath according to any of A0-A0, wherein the inflation    lumen is in communication with a fixed volume syringe for inflation    of the balloon at the proximal end of the sheath body.-   A23. The sheath according to any of A0-A0, wherein the balloon is    inflated via the inflation port with any one of: water, saline and    air.-   A24. The sheath according to any of A1-A23, wherein the balloon is    positioned in-line with the catheter device.-   A25. The sheath according to any of A1-A24, wherein the balloon is    radially symmetric with respect to the longitudinal axis of the    sheath body.-   A26. The sheath according to any of A1-A25, wherein the balloon is    ring-shaped through which the catheter device traverses.-   A27. The sheath according to any of A1-A26, wherein the balloon    applies a radial force on the catheter device when inflated, thereby    locking the catheter device in position.-   A28. The sheath according to any of A0-A0, wherein the balloon is    asymmetric with respect to the longitudinal axis of the sheath body.-   A29. The sheath according to A0, wherein the balloon exerts a force    on the catheter device so as to push the catheter device towards a    portion of the inner surface of the sheath body when inflated,    thereby locking the catheter device in position.-   A30. The sheath according to any of A1-A29, wherein the sheath body    comprises a lamination of a plurality of polymer layers arranged    coaxially with each other about the longitudinal axis.-   A31. The sheath according to any of A0-A0, wherein the sheath body    comprises a combination of a plurality of tubular polymer layer    portions arranged sequentially from the proximal to the distal end    of the sheath body.-   A32. The sheath according to any of A0-A0, wherein each polymer    layer comprises a different polymer material type.-   A33. The sheath according to A0, wherein the polymer material type    comprises any one of: PEBAX® 7233SA, PEBAX® 7033SA, PEBAX® 6333SA,    PEBAX® 5533SA, PEBAX® 3533SA, and PEBAX® 2533SA.-   A34. The sheath according to any of A1-A33, wherein the sheath body    comprises reinforced structures to prevent kinking.-   A35. The sheath according A0, wherein the reinforced structures    comprise any one of: braids, coils and laser cut features.-   A36. The sheath according to any of A1-A35, wherein the balloon is    fabricated from any one of: urethane, polyurethane, polyethylene,    polypropylene, polyethylene terephthalate (PET), polyvinyl chloride    (PVC), polyethylene, cross-linked polyethylene, a polyether block    amide (PEBA), and nylon.-   A37. The sheath according to any of A1-A36, wherein the sheath body    is fabricated from any one of: a polyether block amide (such as    PEBAX® or PebaSlix®), a polyethylene material, a    polytetrafluoroethylene (PTFE) material, a high-density polyethylene    (HDPE) material, a medium-density polyethylene (MDPE) material, and    a low-density polyethylene (LDPE) material.-   A38. The sheath according to any of A1-A37, wherein the distal end    of the sheath body is fabricated from a softer elastic material than    that used for the rest of the sheath body.-   A39. The sheath according to A0, wherein the distal end of the    sheath body comprises a smaller diameter so as to seal onto the    catheter device.-   A40. The sheath according to any of A0-A0, wherein the balloon    sleeve is fabricated from any one of: urethane, polyurethane,    polyethylene, polypropylene, polyethylene terephthalate (PET),    polyvinyl chloride (PVC), polyethylene, cross-linked polyethylene, a    polyether block amide (PEBA), and nylon.-   A41. The sheath according to any of A1-A40, wherein the balloon is    compliant and held flush against the inner surface of the sheath    body when deflated.-   A42. The sheath according to A1, wherein the balloon is    non-compliant and not held flush against the inner surface of the    sheath body when deflated.-   A43. The sheath according to any of A1-A42, wherein the balloon is    coated with a hydrophilic coating.-   A44. The sheath according to any of A0-A0, wherein the balloon is    coated with a hydrophobic coating.-   A45. The sheath according to any of A1-A44, wherein the coating is    of a thickness that ensures appropriate balloon inflation    characteristics.-   A46. The sheath according to any of A1-A45, wherein the sheath body    deforms when the balloon is inflated, thereby fixing the position of    the sheath in the arteriotomy of the patient.-   A47. The sheath according to any of A1-A46, wherein the proximal end    of the sheath is coupled to a hub for manipulating the sheath as it    is positioned within the arteriotomy of the patient.-   A48. The sheath according to any of A0-A0 and A0-A0, wherein the hub    comprises an inflation sideport that is in fluid communication with    the fluid lumen, thereby enabling the attachment of a source of    balloon inflation fluid.-   A49. The sheath according to any of A0-A0, wherein the hub comprises    an irrigation port that is in fluid communication with the space    between the catheter device and the inner surface of the sheath    body, thereby enabling the space to be flushed with fluid prior to    inflation of the balloon.-   A50. A sheath kit for delivery of a catheter device to an    arteriotomy of a patient, the sheath kit comprising:

a sheath according to any of A1-A0; and

a fixed volume syringe filled with fluid and coupled to the sheath forinflating the balloon with the fluid.

-   B1. A method of fabricating a sheath with an internal balloon, the    method comprising the steps of:

providing a tubular sheath body, the sheath body having a longitudinalaxis, an open proximal end, an open distal end, an outer surface and aninner surface, the inner surface defining a lumen between the proximaland distal ends for passage of a catheter device; and

providing an inflatable balloon positioned in the lumen, the balloonconfigured to occupy a space in the lumen between the inner surface ofthe sheath body and the catheter device when the balloon is inflatedthereby sealing the space from the arteriotomy.

-   B2. The method of 0, further comprising:

attaching the inflatable balloon to at least a portion of the innersurface of the sheath body.

-   B3. The method of any of 0-0, further comprising the step of:

pretreating the inner surface of the sheath body to improve adhesionbetween the balloon and the inner surface of the sheath body.

-   B4. The method of 0, wherein the pretreatment comprises any one of:    plasma activation and coronary treatment.-   B5. The method of 0, further comprising:

providing a balloon sleeve for insertion into the lumen of the sheathbody, the sleeve aligned in-line with the catheter device; and

attaching the inflatable balloon to at least a portion of the sleeve.

-   B6. The method of any of 0-0, wherein attachment of the balloon is    carried out via heat or solvent bond.-   B7. The method of any of 0-0, further comprising the step of:

coating the surface of the balloon with either a hydrophilic coating ora hydrophobic coating.

-   B8. The method of 0, further comprising:

coating the surface of the balloon up to a predetermined coatingthickness to achieve particular inflation characteristics of theballoon.

-   B9. The method of any of 0-0, further comprising the step of:

coupling a proximal end of the sheath body to a hub.

-   C1. A method of fabricating a sheath with an internal balloon    according to any of A0-A0.-   D1. A method of using a sheath with an internal balloon for treating    a patient with a catheter device, the method comprising the steps    of:

positioning a sheath according to any one of A0-A0 in an arteriotomy ofthe patient;

inserting the catheter device into the lumen to position a distal end ofthe catheter device in the arteriotomy of the patient;

flushing the space with an irrigation fluid; and

inflating the balloon with an inflation fluid so as to seal the spacefrom the arteriotomy.

-   D2. A method of using a sheath according to 0, further comprising    the step of:

inserting a balloon sleeve on which the inflatable balloon is attachedinto the lumen, the sleeve aligned in-line with the catheter device.

-   E1. A method of inserting a catheter based device through an    arteriotomy of a patient, the method comprising the steps of:

inserting a sheath having a lumen running therethrough into thearteriotomy of the patient;

inserting the catheter based device into the lumen; and

inflating a balloon within the lumen between the sheath and the catheterbased device so as to fluidically seal the lumen.

-   E2. The method of E1, further comprising flushing the lumen prior to    inflating the balloon.-   E3. The method of any of E1-E2, wherein inserting the sheath    comprises inserting a dilator into the lumen of the sheath for    positioning the sheath into the arteriotomy of the patient.-   E4. The method of any of E1-E3, wherein the balloon is attached to    the sheath.-   E5. The method of any of E1-E3, further comprising inserting a    balloon sleeve, onto which the balloon is attached, into the lumen    of the sheath between the sheath and the catheter based device,    before inflating the balloon.-   E6. The method of E5, wherein the balloon sleeve is tightly    coaxially arranged around the catheter based device.

We claim:
 1. A sheath for delivery of a catheter device through anarteriotomy of a patient, the sheath comprising: a tubular sheath bodyhaving a longitudinal axis, an open proximal end, an open distal end, anouter surface and an inner surface, the inner surface defining a lumenbetween the proximal and distal ends for passage of a catheter device;and an inflatable balloon disposed within the lumen and configured to:occupy a longitudinal space in the lumen between the inner surface ofthe sheath body and the catheter device when the catheter device isdisposed within the sheath and the balloon is inflated, and fluidicallyseal the lumen.
 2. The sheath according to claim 1, wherein the balloonforms an interference fit between the catheter device and the innersurface of the sheath body when inflated, thereby preventing any axialmovement of the catheter body
 3. The sheath according to claim 1,wherein the balloon is positioned at least at the distal end of thesheath body.
 4. The sheath according to claim 1, wherein the balloon isattached to the at least a portion of the circumference of the sheathbody.
 5. The sheath according to claim 1, wherein the sheath bodycomprises an inflation lumen that extends linearly or curvilinearly fromthe proximal end of the sheath body to an inflation opening located onthe inner surface of the distal end of the sheath body, wherein theinflation lumen is in fluid communication with the inflation opening. 6.The sheath according to claim 1, further comprising: a balloon sleeve onwhich the inflatable balloon is attached, the sleeve aligned with thecatheter device and traverses the lumen of the sheath body.
 7. Thesheath according to claim 1, wherein the balloon is radially symmetricwith respect to the longitudinal axis of the sheath body.
 8. The sheathaccording to claim 1, wherein the balloon is ring-shaped through whichthe catheter device traverses.
 9. The sheath according to claim 1,wherein the balloon applies a radial force on the catheter device wheninflated, thereby locking the catheter device in position.
 10. Thesheath according to claim 1, wherein the balloon is asymmetric withrespect to the longitudinal axis of the sheath body.
 11. The sheathaccording to claim 10, wherein the balloon exerts a force on thecatheter device so as to push the catheter device towards a portion ofthe inner surface of the sheath body when inflated, thereby locking thecatheter device in position.
 12. The sheath according to claim 1,wherein the distal end of the sheath body comprises anelastic materialthat is softer than a material of the rest of the sheath body.
 13. Thesheath according to claim 1, wherein the balloon is compliant and heldflush against the inner surface of the sheath body when deflated. 14.The sheath according to claim 1, wherein the sheath body deforms whenthe balloon is inflated, thereby fixing the position of the sheath inthe arteriotomy of the patient.
 15. The sheath according to claim 1,wherein the proximal end of the sheath is coupled to a hub formanipulating the sheath as it is positioned within the arteriotomy ofthe patient.
 16. The sheath according to claim 16, wherein the hubcomprises an irrigation port that is in fluid communication with thespace between the catheter device and the inner surface of the sheathbody, thereby enabling the space to be flushed with fluid prior toinflation of the balloon.
 17. A method of fabricating a sheath with aninternal balloon, the method comprising the steps of: providing atubular sheath body, the sheath body having a longitudinal axis, an openproximal end, an open distal end, an outer surface and an inner surface,the inner surface defining a lumen between the proximal and distal endsfor passage of a catheter device; and providing an inflatable balloonpositioned in the lumen, the balloon configured to occupy a space in thelumen between the inner surface of the sheath body and the catheterdevice when the balloon is inflated thereby sealing the space from thearteriotomy.
 18. The method of claim 17, further comprising: attachingthe inflatable balloon to at least a portion of the inner surface of thesheath body.
 19. The method of claim 17, further comprising: providing aballoon sleeve for insertion into the lumen of the sheath body, thesleeve aligned in-line with the catheter device; and attaching theinflatable balloon to at least a portion of the sleeve.
 20. The methodof claim 17, further comprising the step of: coupling a proximal end ofthe sheath body to a hub.